Quality Control/Quality Assurance (QA/QC)

Transferring reliable, robust analytical methods from development to QC

A process, like a human, can’t be strong when its backbone is weak. Reliable, robust analytical tools that are delivered from late development to QC are the backbone of every successful Phase III/commercialization programs.

And we provide the knowledge and tools necessary to successfully transfer your methods: from HPLC to UPLC, or from UPLC to HPLC; from one QC lab to another; from your facility to a partner plant at a different global location.

The successful production of quality pharmaceutical products requires that raw materials meet purity specifications. That manufacturing processes proceed as designed. That final pharmaceutical products meet, and hopefully exceed, defined release specifications. Continued monitoring of material stability is also a component of quality assurance and control.

Waters' HPLC and UPLC systems, paired with Empower CDS Software, are ideally suited for the highly regulated, quantitative analyses performed in QA/QC laboratories.

Integral to many of these configured systems are Waters’ compliant-ready instruments and software — not to mention our robust and consistent columns, compliance services, and training and education courses.

Future-proof your QC lab by upgrading legacy HPLC methods to UPLC

UPLC methods provide a marked reduction in analysis time, improved resolution, and reduced mobile phase consumption. Methods that run on modern chromatographic systems improve laboratory efficiency and productivity, as well as reducing costs for manufacturing facilities.

The supply of consistent, high quality consumable products plays an important role in a registered analytical method. The need for consistency over the lifetime of a drug product — which could be in excess of 30 years — is essential in order to avoid method revalidation and associated production delays.

Waters' manufacturing facilities are registered with the U.S. FDA for the manufacture and distribution of class I medical devices, and are ISO 9001:2000 and ISO 13485:2003 certified. Waters owns and controls every step of the process from raw materials to final product. Very few suppliers do this or are capable of doing this. The management of each step gives us the opportunity control the variability but also to understand the parameters that make a difference to the final product performance.

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Quantification

For bulk product manufacturing, ensure that intermediates have the right profile with speedy and sensitive analyses.